The scope of the EU’s Incentive Framework Research & Development

The Commission’s proposals will need to balance their ambition to improve access to affordable medicines and address unmet need with supporting the EU’s pharmaceutical industry to remain competitive and innovative.

“Our research revealed that whilst the overwhelming majority of MEPs described R&D as a high priority for Europe, others said that improving access to medicine was of greatest significance in addressing healthcare challenges at Member State level. This insight is indicative of the tensions expected to emerge in striking the right balance between these two priorities.

The recently leaked documents highlight that Commission proposals will likely incentivise R&D activity in particular areas where there are high levels of unmet need and in the efforts to produce novel antibiotics.

Conditionality of Intellectual Property Rights

To improve medicine access across the Union, the European Commission is considering legislative measures to compel manufacturers to supply medicines in all EU Member States. This measure is viewed as controversial by the MEPs and industry experts we spoke with.

If the Commission moves to incentivise broader launches, pharmaceutical companies will be forced to think about a wider range of markets from the outset. This will have commercial implications given variabilities within Member States for funding of new medicines. Furthermore, launching products in different economies within a set time period could trigger the unwanted consequence of market shortages due to potential movement of imported medicines between markets.

Some MEPs, particularly those in larger and wealthier Member States, have publicly supportedEFPIA’srecentmembercommitment: “To file for pricing and reimbursement in all EU countries no later than two years after central EU market authorization”

This position has been supported by the publication of additional data which highlights complex processes and delays which hinder national approval of pricing and reimbursement for new medications. Other MEPs believe that the commitment of EFPIA member companies does not go far enough to support the availability of innovation medicines across EU Member States. They believe this is a challenge which can and should be solved at EU level.

The Commission is currently focused on amending Regulatory Data Protection (RDP). RDP is an intellectual property right which provides a period of protection for clinical trial and other test data pharmaceutical companies use to prove a medicine is safe and effective. By making two years of a previously eight-year incentive conditional on product launch in all 27 Member States, the Commission could in some instances enable biosimilar and generic products to enter the market sooner.